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Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04389463
Enrollment
350
Registered
2020-05-15
Start date
2020-05-11
Completion date
2026-06-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Cardiac or Thoracic Surgery

Keywords

Cardiac surgery, Postoperative outcome, COVID-19, SARS-Cov 2 infection, Postoperative complication

Brief summary

This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.

Detailed description

Performing cardiac surgery in the context of SARS-CoV2 infection is potentially at risk of marked post-operative hemodynamic failure (shock) due to the inflammatory reaction generated by the surgery and the extracorporeal circulation associated with the viral infection. In addition, in the absence of infection, 30-50% of patients will experience acute post-operative respiratory failure due to the combined effects of extracorporeal circulation and general anesthesia. The pulmonary tropism of the virus therefore is susceptible to increase in post-operative respiratory impairment. Thus, the infection is likely to favor the occurrence of post-operative shock but also to aggravate respiratory failure and other post-operative organ failures. Therefore, the investigators designed an observational study that aims at comparing two groups of patients: * Cardiac or thoracic surgery patients with a negative Covid-19 PCR pre-operatively and in the 15 following days * Cardiac or thoracic surgery patients with a positive Covid-19 PCR in the 15 days before surgery

Interventions

OTHERNo intervention

No description

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adults (age ≥18 years) undergoing cardiac or thoracic surgery * With positive PCR in the 5 days before or after cardiac/thoracic surgery.

Exclusion criteria

* Minors

Design outcomes

Primary

MeasureTime frameDescription
Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.12 hours post-operativelyThe VIS score correlates with mortality after cardiac surgery and reflects the degree of patient hemodynamic failure. This score is calculated as follows: ISR = Dobutamine dose in g/kg/min + 100 times the Adrenaline dose in g/kg/min + 100 times the Noradrenaline dose in g/kg/min + 10,000 times the Vasopressin dose in U/kg/min.

Secondary

MeasureTime frameDescription
Post-operative organ failure5 days post-operativelyProspective assessment of ICU outcomes until all included patients were discharged from ICU
Post-operative outcome28 days post-operativelyProspective assessment of ICU outcomes until all included patients.

Countries

France

Contacts

Primary ContactMickael VOURC'H, MD
vourchm@gmail.com0253482835
Backup ContactAnnick COULON
bp-prom-regl@chu-nantes.fr0253482835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026